SD0006 check - Baseline Flag

Pinnacle 21 Support SDTM
1

Hi Manolya,

If baseline assessments were NOT DONE, then it’s a huge data quality issue. Actually it means that you are loosing this subject from analysis of study data.

Kind Regards,

Sergiy

2

Dear Sergiy,

It is a study where only pregnancy test was perfomed. Therefore, male subjects have a “NOT DONE”. So I will probably have to explain it that way.

Thanks!

3

Hi!

The SD0006 check says that “All subjects should have at least one baseline observation (–BLFL = ‘Y’) in EG, LB, QS, and VS domains, except for subjects who failed screening (ARMCD = ‘SCRNFAIL’) or were not fully assigned to an Arm (ARMCD = ‘NOTASSGN’)”. However, what if lbtests are “NOT DONE”. Here I do not see to set a baseline flag. Is this check then obsolete?

Thanks!